Medicaments and other pharmaceutical preparations are often prescribed for a timed therapy. In the case of solid dosage forms, such as tablets or pills, the drug dose is in premeasured units and the therapy is dependent upon the administration of multiple units over a course of time. Often, this administration is done by the patient at home and away from the discipline of the clinical environment. In this circumstance, packages which assist the patient to be compliant with the regimen of therapy are of particular value.
Frequently the course of solid dose therapy requires a periodic habit. Tablets or pills used for birth control, for regulating blood pressure, for antibiotic administration, for maintenance of a diabetic condition, and for a variety of other ailments are taken in regular intervals over extended periods of time. Sometimes the tablets or pills are organized into cycles which are replenished at anniversaries of the starting time. In the case of some preparations, such as birth control pills, the drug dose is sometimes varied within a discrete serial of pills in order to administer the minimal amount of drug as required by a time-phased bodily cycle, such as ovulation. In other circumstances, placebos are added to the regimen at an appropriate interval to fill out the cycle. In all such cases, it is important for the package to maintain the pills in a specific sequence.
Sequence-maintaining tablet dispensers and devices for dispensing solid form pharmaceutical preparations are known. Occasionally these are in the form of push-through blister packages consisting of a film, such as polyvinyl chloride, formed into pockets which contain the pills, lidded over with a frangible material, such as aluminum foil. The sequence is indicated by an array in rows representing a cycle by the left-to-right convention; or, otherwise, in a loop, such as a circle or oval, with a defined circuit direction. Sometimes the pills are contained in the individual cells of a rigid container formed of a molded plastic. In such containers, the cells are typically in a circular array that can be indexed to a fixed dispensing location where a selected pill can be expelled through an exit feature. The period or cycle is usually indicated by labelling which is pre-applied to the dispenser by the manufacturer or, otherwise, can be applied by the patient. When the labelling is pre-applied, it is sometimes provided with an adjustment feature, The patient-applied, or adjusted, labelling allows for a variable start to the period of administration which is otherwise fixed by the species of the dispenser provided. In the case of birth control pills, the cycle is typically either 21 or 28 days, the labelling indicates days-of-the-week, and the fixed start day is usually Sunday.
The aspect of patient compliance with respect to drugs administered in dispensing systems has been studied. The regularity of patient behavior is vitally important to the therapy. If birth control pills are not taken daily when indicated, for example, there is a risk for pregnancy, constituting a catastrophic failure of the therapy. Making up the missed pills at a later time is not always effective. Healthcare today is tending more and more toward self-care at home. Packages which assist the patient in compliant behavior, therefore, are becoming increasingly important for efficacy.
Two of the factors which significantly influence desired behavior are limiting the choices to be made by the patient and making the package system convenient to use. Regarding the first factor, the patient using a typical pill dispensing package is guided to a sequence by labeling, or by convention, but is still required to make a selection of the correct pill, This selection process is simplified in the single-port dispensing systems, wherein the pill array is rotated or transported to a single exit port, by reducing the selection process to a simple indexing action, such as advancing the mechanism one position. Even in the single-port dispensing system, however, a mistake can be made by advancing too far. In fact, any single pill within any package of today's technology can be taken at will by the patient.
Convenience is also linked to compliance. Incentive to comply is normally provided by the ailment or condition treated or prevented by the drug therapy. It is well known, however, that compliance sometimes lapses even under such incented circumstances when the administration spans long periods of time. In the case of birth control, the administration period can last for years, possibly spanning the whole of fertile adulthood. The key to compliance, therefore, is to establish a habitual behavior that becomes automatic without reliance upon aids for memory. Since incentive is already provided, enhancement can be directed to the removal of disincentives. One type of disincentive is the multiple-step operation procedure of the dispensing package. After an initial set up, the typical sequence-maintaining package requires two operational steps for actuation. The first is to select the correct pill, aided by the labeling, and the second is to express the selected pill. An improvement would be to select unaided and express, all in one single step.
It is therefore an object of the present invention to regulate access to the pills such that only the correct pill of the sequence can be dispensed in any dispensing episode. Further, the present invention provides a convenient one-step, self-actuating mode of operation. Other features and purposes of the present invention include the provision of a protective envelope in the form of a shell for maintenance of the pill regimen during the administration period and the capability of replenishing the pill regimen through provision of a refill unit, thereby allowing reuse of the durable envelope and preventing wastage of valuable material. Also included is the capability of customizing a starting indicator of periodicity for the regimen through adjustable labeling. As the labeling is no longer needed with the present invention to aid in selection, it serves to reliably remind the patient if the dispensing event has already occurred. It is a further object of the present invention to enhance manufacturability by providing, through design, componetry which can be fabricated with homogeneous materials and processes and which can be easily assembled by interlocking fits.